A Pilot, Single Arm Post-Market Clinical Study to Demonstrate the Feasibility, Safety and Efficacy of PuraBond™ Absorbable Haemostatic Material for the Management of Bleeding and Tissue Healing in Robotic Partial Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intraoperative efficacy rate in stopping remaining mild and moderate bleeding after declamping within 2 minutes
研究概览
简要总结
Kidney cancer is one of only a few cancers with an increasing incidence over the past two decades. Renal cell carcinoma (RCC) accounts for over 85% of all kidney tumours, which makes up 2-3% of all adult malignancies. Approximately, 70% of RCCs are incidentally discovered on axial imaging of the abdomen with >50% of RCCs being low-stage (T1-T2 N0M0). Despite advancements in drug discovery for advanced RCC, mortality rates have not changed over the past two decades, however for patients with the low-stage disease, surgical extirpation offers excellent 5-year survival rates of 95%.
Nephron-sparing surgery (NSS) provides effective curative therapy for patients with localized renal cell carcinoma with the benefit of kidney preservation and excellent cancer-specific survival. However, the most frequent complications during NSS, after tumour resection are bleeding, urinary fistula formation, and ischemic renal damage. More precisely, the urological complication was defined as significant haemorrhage >500 mL necessitating intervention or transfusion, urine leakage (drainage of greater than 50 mL daily for more than one week with fluid biochemistry compatible with urine) and acute renal failure (resulting in any dialysis, ureteral obstruction or kidney loss).
In the field of partial nephrectomy procedures, it is therefore crucial achieving adequate haemostasis intraoperatively during post tumour excision while the artery is clamped and after being unclamped.
详细描述
Kidney cancer is one of only a few cancers with an increasing incidence over the past two decades. Renal cell carcinoma (RCC) accounts for over 85% of all kidney tumours, which makes up 2-3% of all adult malignancies. Approximately, 70% of RCCs are incidentally discovered on axial imaging of the abdomen with >50% of RCCs being low-stage (T1-T2 N0M0). Despite advancements in drug discovery for advanced RCC, mortality rates have not changed over the past two decades, however for patients with the low-stage disease, surgical extirpation offers excellent 5-year survival rates of 95%.
Nephron-sparing surgery (NSS) provides effective curative therapy for patients with localized renal cell carcinoma with the benefit of kidney preservation and excellent cancer-specific survival. However, the most frequent complications during NSS, after tumour resection are bleeding, urinary fistula formation, and ischemic renal damage. More precisely, the urological complication was defined as significant haemorrhage >500 mL necessitating intervention or transfusion, urine leakage (drainage of greater than 50 mL daily for more than one week with fluid biochemistry compatible with urine) and acute renal failure (resulting in any dialysis, ureteral obstruction or kidney loss).
In the field of partial nephrectomy procedures, it is therefore crucial achieving adequate haemostasis intraoperatively during post tumour excision while the artery is clamped and after being unclamped.
Haemostatic agent can be used after Robotic-assisted laparoscopic partial nephrectomy (RLPN) or after the sutureless technique with bipolar cauterization of the surgical bed for the haemostatic control in the treatment of small cortical masses. It can be always used for tumours ≤1.5 cm and can be a valid option also for tumours between 1.6 and 2.5 cm, aside from their spatial extension.
As such, there is a need for the exploration of the use of novel haemostatic agents, such as self-assembling peptide (SAP)-based haemostat, to manage bleeding during partial nephrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, aged 18 years or above
- •Patient has a clinical indication for laparoscopic partial nephrectomy procedure
- •Participant is willing and able to give informed consent for participation in the study
- •Intraoperative criteria: Subject requiring the use of PuraBond for persisting mild and moderate bleeding(s) when haemostasis by ligation or standard means are insufficient or impractical.
排除标准
- •Pregnant or Lactating women
- •Unable to give informed consent
- •Patient undergoing redo surgery
- •Fibrin glue and/or topical haemostatic agent used before or concomitantly to the use of PuraBond
- •Known allergy or hypersensitivity to any component of the investigational treatment PuraBond
- •Known coagulopathy
- •Clinical indication not satisfying inclusion criteria
- •Patient has clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the study duration
- •Patients currently participating in, or planning to enroll in another clinical study that may impact participation or outcomes of this clinical study.
研究组 & 干预措施
PuraBond
Collect medical information on patients who were treated with PuraBond during robotic partial nephrectomy, according to each participating institution's procedures and standards of care.
Evaluate the feasibility, safety and efficacy of PuraBond in achieving haemostasis and post operative healing at the resection site compared to standard of care agent for robotic partial nephrectomy procedures
干预措施: PuraBond (Device)
结局指标
主要结局
Intraoperative efficacy rate in stopping remaining mild and moderate bleeding after declamping within 2 minutes
时间窗: During robotic partial nephrectomy procedure
次要结局
- Radiomics score of tissue healing at 6 months post op CT scan(6 months)
- Time to Haemostasis after PuraBond application(During robotic partial nephrectomy procedure)
- The amount of PuraBond needed to achieve haemostasis(During robotic partial nephrectomy procedure)
- Ease of use of PuraBond (difficult or easy)(During robotic partial nephrectomy procedure)
- Rate of revision for bleeding(During robotic partial nephrectomy procedure)